FDA approves a dedicated syringe to be used with Humulin R U-500 insulin- Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration approved a dedicated syringe for the administration of Humulin R U-500 insulin, which is now the only device approved for use with U-500 insulin vial.

Humulin R U-500 insulin vial has been available with no dedicated device for delivery since 1994. To administer the insulin, healthcare practitioners and patients had to make dose conversions to deliver the appropriate dose using a U-100 insulin syringe or a tuberculin (volumetric) syringe. Since conversions are no longer needed with this new device, the Humulin R U-500 insulin vial label will be updated to remove the dose conversion information for U-100 and tuberculin syringes.

Approved syringes for use with Humulin R U-500 insulin vials will only be available with a prescription and should be co-prescribed with U-500 insulin. Humulin R U-500 is also available in a prefilled pen device as well as a vial. For patients that do not use the pen, the vial can be used as an alternative. If patients are hospitalized or transitioning care, their dose of Humulin R U-500 should be clearly communicated to hospital staff. Patients who are prescribed Humulin R U-500 insulin should be aware of the following:

• Only use the U-500 insulin syringe with the U-500 insulin vial.
• Do not switch between types of syringes because it may increase the risk of dosing errors.
• Maintain an adequate supply of U-500 insulin syringes. Patients should not attempt to dose with another type of syringe if their supply of U-500 insulin syringes runs out, but instead call their pharmacist or healthcare professional immediately for further instruction.

To view the full statement, please visit: Humulin R U-500 insulin.